NCT05084092招募中2 期
IORT After Surgical Resection of Brain Metastases: Feasibility and Efficacy Phase II Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Median local progression free survival (PFS)
研究概览
简要总结
To evaluate the feasibility and efficacy of the Intraoperative Radiation Therapy (IORT) after the resection of a brain metastases to reduce the incidence of local relapse
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years, Karnofsky Performance Index ≥
- •Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1- weighted MRI scan) amenable to total resection with no dural attachment.
- •Frozen section confirming a metastasis of an extracranial (i.e. non-CNS) tumor.
- •Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy).
- •Adequate birth control.
- •Informed consent.
排除标准
- •Leptomeningeal spread and dural attachment (assessed pre- and intraoperative).
- •Frozen section reveals primary CNS tumor, lymphoma, SCLC or germinoma.
- •Psychiatric or social condition potentially interfering with compliance.
- •Contraindication against anesthesia, surgery, MRI and/or contrast agents.
- •Pregnant or breast-feeding women.
结局指标
主要结局
Median local progression free survival (PFS)
时间窗: 12 months
Time span (in months) between surgery and recurrence within a 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.
次要结局
- Median time to the initiation of systemic therapies(12 months)
- Median overall survival (OS)(12 months)
- Median regional PFS (rPFS)(12 months)
- Change in neurocognitive performance (compared to baseline): Repetition(6, and 12 months)
- Radiation-related (acute / early delayed / late) neurotoxicity(12 months)
- Change in neurocognitive performance (compared to baseline): Minimental(6, and 12 months)
- Global PFS (gPFS)(12 months)
- Quality of life (QoL)(6, and 12 months)
- Change in neurocognitive performance (compared to baseline): Semantic(6, and 12 months)
- Change in neurocognitive performance (compared to baseline): Trail making(6, and 12 months)
- Change in neurocognitive performance (compared to baseline): Oral(6, and 12 months)
研究者
研究点 (2)
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